Safety Scientist SERM (Safety Evaluation and Risk Management)
- Bachelors level or above degree in a biomedical or health care-related specialty.
- 2-3 years clinical safety experience or equivalent experience ( e.g. clinical development in a pharmaceutical company, regulatory authority etc.)
- Basic understanding of safety evaluation methodology/ process awareness of pharmacovigilance regulations and methodologies.
- Understanding of medical terminology.
- Experience in drafting responses to ad hoc queries or evaluating significant safety issues for regulatory submissions (e.g., PSURs ) under supervision.
- High degree of accuracy with attention to detail.
- Detail oriented, methodical and analytical approach.
- Good communication skills, team player, flexible.
- Ability to manage crisis, monitor safety issues and work under pressure with a customer and solution oriented approach.
- Able to prioritize activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
- Demonstrate initiative and creativity in performing task and responsibilities. Proactively contributes ideas to improve existing operations
- Demonstrated writing skills.
- Computer literate, familiar with using scientific and clinical databases.
You will work with the SERM physician to actively manage and evaluate risks associated with assigned vaccine projects, and make recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks.
This may involve the following:
- Coordinate and perform initial analyses of adverse event reports and/or signal detection activities for assigned vaccine projects in clinical development and post-licensure
- Be the safety contact person for Clinical, Regulatory Affairs, regional and LOC (local operating company) safety managers, manufacturing teams for assigned vaccine projects
- Provide input to Clinical Teams with respect to safety aspects of the design and preparation of protocols, investigators brochures, investigator letters and reports, for the follow up and processing of clinical study data and lead the safety analyses of the assigned projects.
Location: Rockville, Md
You may apply for this position online by selecting the Apply now button.
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